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Senior Scientist II, Quality Control
Overseeing the whole Analytical lifecycle
Clinical stage Biotech creating a new generation of therapeutics that improve patient outcomes and, in the process, build shareholder value.
They are developing a deep pipeline of innovative therapeutics for diseases with a genetic basis. The depth and versatility of their technology gives an opportunity to address a wide range of conditions in virtually any therapeutic area. Their wholly owned pipeline is currently focused in three therapeutic areas of high unmet need: hematology, cardiovascular, and rare diseases.
The company is growing its CMC team to support their maturing pipeline and approach to GMP Compliance. A key piece to this is strengthening their Analytics and Quality Control methodologies.
As Senior Scientist II, Quality Control, you will be joining the growing CMC GMP Quality Team, while being an integral part of the broader Analytical community in CMC.
You will guide and oversee the development of new analytical methods across all aspects of the lifecycle, including method transfer to CROs and CMOs, validation and ongoing monitoring.
You will provide Quality level oversight to analytical activities performed at CMOs related to GMP manufacturing and help resolve any issues related to analytics. Additionally, you will serve as a GMP subject matter expert for all topics related to analytics, providing guidance to colleagues in product and impurity characterization, method development and transfer.
Finally, you will support development of documentation enabling successful Regulatory submissions to help move the pipeline closer to market.
Experience and Qualifications